Changes with the potential to impact the content of the CTD require a thorough assessment to determine the appropriate course of action. The change control impact assessment of ANDA/DMF must include a full understanding of the change, visibility of all impacted products (i.e., finished products and APIs) and must determine all countries where those products are registered. This might also include countries where a new product submission or approval is pending.
As registered details for a product can differ between countries, it is essential to review all amendments of the relevant registered information so that a complete change control impact assessment can be performed taking into account the regulations and guidelines applicable in the intended country (i.e. the US) where the product is approved. The change control impact assessment will determine the classification of the change and the required supporting documentation.
A robust change control assessment of the product is critical in developing a suitable DMF/ANDA change submission strategy and ensuring continued product compliance. Freyr’s Regulatory affairs team has extensive knowledge and experience in change control assessment, post-approval submission strategy and preparation of change-related submission packages as per the Health Authority requirements and guidelines.
Evaluation of change control and supporting documents as per the USFDA guidelines
Preparation of a post-approval submission strategy for the proposed change
Providing the list of supporting documents/data to be included/generated
Guidance on the implementation strategy for the proposed change
Preparation of supporting Regulatory documentation (e.g., revised Module 3 sections, Module 1 documentation) for finished products and APIs